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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal failure) using Continuous Renal Replacement Therapies, such as continuous hemodialysis and hemodiafiltration aimed at normalizing the composition of the blood. The product may also be used in case of drug poisoning with dialyzable or filterable substances.
BAXTER INTERNATIONAL INC.
106957
In Commercial Distribution

  • 37332414066834 ()
  • 07332414066833 ()
106957S

  • Haemodialysis dialysate solution
The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal failure) using Continuous Renal Replacement Therapies, such as continuous hemodialysis and hemodiafiltration aimed at normalizing the composition of the blood. The product may also be used in case of drug poisoning with dialyzable or filterable substances.
BAXTER INTERNATIONAL INC.
105351
In Commercial Distribution

  • 37332414037049 ()
  • 07332414037048 ()
105351S

  • Haemodialysis dialysate solution
The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal failure) using Continuous Renal Replacement Therapies, such as continuous hemodialysis and hemodiafiltration aimed at normalizing the composition of the blood. The product may also be used in case of drug poisoning with dialyzable or filterable substances.
BAXTER INTERNATIONAL INC.
105353
In Commercial Distribution

  • 37332414037032 ()
  • 07332414037031 ()
105353S

  • Haemodialysis dialysate solution
dialysis solution,ml 500+4500
Mozarc Medical US LLC
MD088
In Commercial Distribution

  • 08051411600350 ()
  • 38051411600351 ()

  • Total Volume: 5000 Milliliter


  • Haemodialysis dialysate solution
dialysis solution,ml 500+1500 each
Mozarc Medical US LLC
MD042
In Commercial Distribution

  • 10884521807990 ()
  • 38051411600061 ()

  • Total Volume: 2000 Milliliter


  • Haemodialysis dialysate solution
The PrisMax control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy
BAXTER HEALTHCARE CORPORATION
955626
In Commercial Distribution

  • 00085412639499 ()
955626

  • Haemodialysis system, institutional
The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy
GAMBRO AB
7.20
In Commercial Distribution

  • 07332414124236 ()
955542

  • Haemodialysis system, institutional
The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy
GAMBRO AB
7.XX
In Commercial Distribution

  • 07332414117702 ()
115269

  • Haemodialysis system, institutional
The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy.
GAMBRO AB
7.21
Not in Commercial Distribution

  • 07332414126766 ()
955792

  • Haemodialysis system, institutional
The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy.
GAMBRO AB
5.XX
Not in Commercial Distribution

  • 07332414105266 ()
113081

  • Haemodialysis system, institutional
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